MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2003-01-24 for ONE TOUCH II manufactured by Lifescan, Inc..
[379562]
A pt reported blood glucose results of 115 mg/dl with a lifescan meter and 90 mg/dl on a laboratory device, performed within 15 minutes of each other. Between the tests there was no interventionthat would be expected to change the blood glucose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939301-2003-00762 |
| MDR Report Key | 595001 |
| Report Source | 01,04 |
| Date Received | 2003-01-24 |
| Date of Report | 2003-01-24 |
| Date Mfgr Received | 2003-01-24 |
| Date Added to Maude | 2005-04-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALAN CARISIKI, MD, JD |
| Manufacturer Street | 1000 GIBRALTAR DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal | 95035 |
| Manufacturer Phone | 4089564515 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE TOUCH II |
| Generic Name | BLOOD GLUCOSE MONITORING KIT/SYSTEM |
| Product Code | CFE |
| Date Received | 2003-01-24 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 584832 |
| Manufacturer | LIFESCAN, INC. |
| Manufacturer Address | 1000 GIBRALTAR DR. MILPITAS CA 95035 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-01-24 |